Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products

NCT00263809 | Completed Early Phase 1

• 1 other identifier: CTS-0028
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 10

Brief Summary

The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).

Conditions

Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• The platelet corrected count increment measured 1 hour post transfusion.

Secondary Outcomes (11)

• The platelet corrected count increment measured 24 hours post-transfusion.

• The number of days between platelet transfusions during the period of the study.

• The number of platelet transfusions per subject.

• The number of platelets infused per subject.

• The number of platelets used.

Study Arms (2)

1

EXPERIMENTAL

Treatment, Mirasol-treated platelets

Device: Pathogen Reduction Technology

2

NO INTERVENTION

Reference, Untreated platelets

Interventions

Pathogen Reduction Technology DEVICE

1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of age of 16 years or older
• Women of Child Bearing Potential not pregnant
• Subject must have signed and dated the Informed Consent form
• Hospitalized, thrombocytopenic subjects and expected to receive at least two platelets transfusion

You may not qualify if:

• History of any hypersensitivity reaction to riboflavin or metabolites
• History of refractoriness to platelet transfusions
• Positive lymphocytotoxic antibody test
• Active bleeding
• Splenomegaly
• Acute or chronic Disseminated Intravascular Coagulation
• History or diagnosis of Immune/Idiopathic Thrombocytopenic Purpura, Thrombotic Thrombocytopenia Purpura, or Haemolytic Uremic Syndrome
• History or diagnosis of an autoimmune disease affecting haemostasis
• History of solid organ transplants
• Evidence of occlusive venous disease
• Pregnant or lactating females
• Chronic alcohol misuse
• Use of prohibited medications

Sponsors & Collaborators

• Terumo BCTbio: lead

Study Sites (10)

Centre Hospitalier Universitaire Jean Minjoz

Besançon, 25020, France

Location

EFS Bourgogne - Franche-Comté

Besançon, 25020, France

Location

EFS Aquitaine

Bordeaux, 33035, France

Location

Centre Hospitalier Univesrsitaire A Michallon

La Tronche, 38043, France

Location

EFS Rhône-Alpes (Site de Grenoble)

La Tronche, 38701, France

Location

EFS Pays de la Loire

Nantes, 44011, France

Location

Centre Hospitalier Universitaire Hôtel Dieu

Nantes, 44035, France

Location

Centre Hospitalier Universitaire de Bordeaux

Pessac, 33604, France

Location

Centre Hospitalier Régional Universitaire Hautepierre

Strasbourg, 67000, France

Location

EFS Alsace

Strasbourg, 67065, France

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Jean-Pierre Cazenave, MD

  Director - EFS Alsace - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 7, 2005
• First Posted: December 9, 2005
• Study Start: December 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 7, 2009

Record last verified: 2009-10

Locations

FR (10)